Method and device for the endoscopic application of self-closing medical clips

ABSTRACT

The invention relates to a method for the endoscopic application of self-closing medical clips ( 3 ), in particular, for arresting internal bleeding, whereby the distal end of a catheter tube ( 1 ) is introduced into the body of a living being to be treated; several clips ( 3 ), arranged successively in the catheter tube ( 1 ), are pushed forward in the direction of the distal end thereof by means of a user device which is located at the proximal end of the catheter tube ( 1 ); the foremost clip ( 3 ) to be applied is pushed out of the distal end and opened by an actuation device. Said actuation device comprises an actuation element ( 21 ) which can be actuated by the user device, moved longitudinally into the catheter tube ( 1 ) and acts on the first front clip ( 3 ), as well as a control part ( 25 ) which converts the actuation force of said actuation element into an opening movement of the legs ( 5 ) of the clip ( 3 ). After the opening of said clip ( 3 ), the actuation element ( 21 ) is separated from the clip ( 3 ), for releasing said clip in order to close the legs ( 5 ) thereof for application, and functionally linked with the following clip ( 3 ) in the catheter tube ( 1 ). The invention also relates to a device for carrying out said method.

The invention relates to a method for endoscopic application of self-closing medical clips, especially for stopping internal hemorrhages, in which a catheter tube with its distal end is placed in the body of the living being to be treated. Moreover the invention relates to a device for implementing said process.

Different processes using flexible endoscopes are known for stopping internal hemorrhages, for example in the upper or lower gastrointestinal tract, for example from varicose hemorrhages, post-polypectomy hemorrhages or ulcerative hemorrhages. Examples include coagulation, sclerosing, ligature, or application of self-closing clips. All the known processes are subject to disadvantages in various respects, whether the therapeutic success is not satisfactory or use is complex or very expensive. Recently as the preferred process the clip procedure has become established as being relatively favorable, that is, subject to few disadvantages. Further applications of these clips can be found in the area of attaching markers for identification of diagnostic or x-ray sections and surgical treatment procedures, for example removal of polyps in the gastrointestinal tract.

In the clip procedure a metallic clip is pushed out of the distal end of a catheter tube, opened and placed at the hemorrhage site such that it forms a clamp which clamps off the hemorrhage. U.S. Pat. No. 5,174,276 shows a device which is designed for implementing this clip procedure.

When the clip procedure is being carried out, in many cases several clips are needed to stop the bleeding. In the known clip procedure this disadvantageously leads to delays in the course of the treatment because the applicator device must be removed from the body each time for re-seating of clips, provided with another clip, reinserted into the body with the catheter tube and placed at the treatment site. This leads not only to a prolongation of the course of treatment, which can result in serious danger to the patient in a case of heavy bleeding, but also entails the danger of faulty placement.

On the basis of this prior art, the object of the invention is to devise a process which permits multiple placement of hemostatic clips in immediate succession, without the need to provide the endoscopic device with another clip outside of the body for each application.

This object is achieved by a process which has the features cited in claim 1.

In that, as claimed in the invention, the catheter tube itself is used as a magazine which is loaded with several clips before implementing the pertinent treatment, multiple application of hemostatic clips in immediate succession is made possible without the respective endoscopic device needing to be removed from the body after each application. Rather the respective frontmost clip can be pushed out of the distal end of the catheter tube, opened by means of the actuating element acting on it, and placed on the hemorrhage site to be treated. The actuating element is detached from the clip so that it is released and its self-closing legs effect the hemostatic clamping, after which the actuating element is functionally linked to the clip which follows in sequence in the catheter tube, so that if necessary the next clip can be applied without delay. Preferably the clips are already loaded by the manufacturer; but in particular in the case of special applications is it also possible to magazine the clips on site, that is to say, at the site of the procedure. Preferably flexible spiral tubes which are resistant to tension and compression, but also tube-like flexible application bodies can be used as the catheter tube.

The subject matter of the invention is a device for implementing the process. The device as claimed in the invention has the features specified in claim 2; its initial part (preamble) which precedes the characterizing part is based on the prior art disclosed in U.S. Pat. No. 5,174,276 indicated in the foregoing.

In the device as claimed in the invention the control part which converts the actuation force of the actuating element, which can be controlled by the operator means of the device into the opening motion of the legs of the clip, is located on the distal end of the sleeve-like receiving part which is associated with the respective clip. The latter is shaped on its legs which are adjacent to each other such that when the clip is inserted into the receiving part, an opening motion of the free leg ends takes place by the kink of the two legs which forms an arch striking the control part. If after opening the clip the kink on the legs is disengaged from the sleeve-like receiving part by means of the actuating element, the legs of the clip are released again in order to be closed by their own elasticity at the application site. This closing process can be further promoted by deformation at the respective kink of the clip effected by the sleeve-like receiving part and in certain configurations can also be replaced exclusively by the indicated deformation.

The actuating element can be a pulling element and the control part can be a beveled control surface located on the end edge of the sleeve-like receiving part. The opening and subsequent closing of the legs of the clip which is to be applied are effected by pulling the clip into its receiving part, the opening motion taking place by the kink of the legs striking the control surface. Subsequently pulling the kinks through the receiving part effects the clip legs being released for the closing motion as soon as the kinks of the legs have run through the sleeve-shaped receiving part. The beveled control surface can also be formed by the curved control surface's running convexly or concavely.

The pulling element can be a pull cable, and for its connection to the pull cable on its back end crosspiece which connects the legs each clip can have two adjacent through holes through which the pull cable is guided in a loop such that it extends in an advancing strand to the clip and back from the latter back in a retreating strand to the operator means. If in this case the section of the end crosspiece of the clip which is located between the through holes is made as a predetermined breaking point which can be broken by the pulling force of the pull cable acting by way of the loop, the pull cable can be easily detached from the clip after completion of the actuating process.

The procedures of pulling the clip into the receiving part and of detaching the pull cable from the applied clip are especially safe, i.e., without the danger of the clip's changing location by the force applied by the pull cable at the predetermined breaking point, when on the distal end of the catheter tube there is a blocking element permitting the passage of the sleeve-like receiving part with the respective clip only in the exit direction forward but which supports the sleeve-like receiving part against the motion effected by the pulling force of the pull cable.

In an especially advantageous manner these embodiments can be further configured such that in the catheter tube there are several clips with the respective sleeve-like receiving part in succession and that the pull cable with the advancing strand and with the retreating strand is guided in each case through one or the other through hole of the end crosspieces of all clips.

With such a structure of the device several clips can be applied in direct succession because, after the pull cable is pulled off, the applied clip the device is immediately functionally linked to the respective following clip by pulling on the pull cable; this takes place by the pull cable on the end crosspiece of the following clip automatically forming a loop assembly. Thus, without any other measures being necessary, the device is immediately prepared for application of the following clip.

The invention is detailed below using one embodiment shown in the drawings in which

FIG. 1 shows a schematically simplified longitudinal section of only the distal end section of the catheter tube as a component of one embodiment of the device as claimed in the invention; this section is shown on an enlarged scale compared to the natural size;

FIG. 2 shows a perspective oblique view of a self-closing medical clip drawn on a still larger scale, for use in the device as claimed in the invention;

FIG. 2 a shows a further enlarged perspective of only the end crosspiece of the clip from FIG. 2, which crosspiece is provided with a predetermined breaking point;

FIGS. 3 and 4 shows operating sketches simply for illustration of the movements and forces for opening of the clip;

FIGS. 5 to 13 show schematics of only the distal (front) end of the catheter tube shown in FIG. 1 with the clip having emerged and with the respective sleeve-like receiving part, successive operating states being shown as the opening and closing cycle of the clip proceeds, and

FIG. 14 shows a highly enlarged perspective view of a blocking element designed as a collet for the distal end of the catheter tube.

FIG. 1 shows the distal end section of the catheter tube 1 as a component of the embodiment of the device as claimed in the invention which is to be described. The catheter tube 1 extends through the associated working space of a flexible endoscope which can be of conventional design in medical technology and which contains at least one other inner working space for endoscope optics including illumination and/or for other purposes (for example, suction). The proximal end of the catheter tube 1 which is not shown is functionally connected to the manipulation and operator means located on the respective end of the endoscope. The outside diameter of the catheter tube 1 is 2.7 mm corresponding to the clearance of the working spaces in flexible endoscopes.

The device as claimed in the invention is suited for application of self-closing medical clips of a design as can be seen most clearly from FIGS. 2 to 4. As is to be seen, the clip which is designated as a whole as 3 and which is formed from a material such as high quality steel customarily used for medical purposes, has two legs 5 which, without crossing one another, are adjacent to each other and are bent toward each other on the free leg end 7. On the end opposite the leg end 7 the legs 5 are connected to each other by an end crosspiece 9 which is pulled through two through holes 11 adjacent to each other. Offset from the end crosspiece 9 against the free leg end 7 each leg 5 has a first kink 13 which is arched to the outside, and further offset against the leg end 7, a second kink 15 to the inside, which latter together form a support point for the mutual contact of the legs 5. From the second kink 15 the remaining sections of the legs 5 extend running more or less parallel to the free leg end 7 when the clip 3 is in the closed state, as is shown in FIGS. 2 and 3, which otherwise relate to the initial state of the clip 3.

The functional diagrams of FIGS. 3 and 4 using the sleeve 17 and a counter bearing 19 show the forces which effect opening of the legs 5 under the action of a pulling force applied by means of a pull cable 21 to the clip 3 corresponding to the action arrow 23 in FIG. 4. Upon contact with the beveled control surface 25 on the end edge of the sleeve 17, a force which is directed inwardly, see arrow 27, acts on the first kink 13, the legs 5 being extended (see arrows 29 from FIG. 3) with the second kink 15 for mutual support. Due to the pulling force which continues to act (arrow 23) the legs 5 at the support point of the second kink 15 seesaw on each other, which results in the opening-pivoting of the legs 5 according to arrows 31 (FIG. 4).

FIG. 1 shows that in the catheter tube 1 there are several clips 3 in succession which each form a unit with a sleeve-like receiving part 33. In its operation the receiving part 33 corresponds in the interaction of its front control surface 25 with the respective clip 3 of the sleeve 17, as shown in FIGS. 3 and 4 to illustrate the forces acting on the clip 3. In FIG. 1 two clips 3 with the respective receiving part 33 are accommodated in the catheter tube 1. But in practical application the catheter tube 1 can be provided as a magazine for 2 to 10 clips, preferably for 2 to 5 clips or more. As FIG. 1 shows, the units consisting of the clip 3 and receiving part 33 can be moved in the catheter tube 1 by means of a sliding tube 35 with a front end edge 37 which forms a plunger for contact with the adjacent receiving part 33 and with a proximal end which can be manipulated as part of the actuating means from the operator means on the outer actuating end of the endoscope.

As is likewise apparent from FIG. 1 in conjunction with FIGS. 2 to 4, the pull cable 21 extends in the catheter tube 1 as the actuating element in two strands 24 through the through holes 11 (see FIG. 2) of each clip 3, on the frontmost clip 3 a loop 39 being formed on the end crosspiece 9 (FIG. 1). The loop 39 is also shown in the schematics of FIGS. 3 and 4. The strands 24 of the pull cable 21 are routed in the catheter tube 1 through the sliding tube 35 as the actuating element as far as the operator means on the outer end of the endoscope.

When the device is being used, the clips 3 which are arranged in succession in the catheter tube 1 with the associated receiving parts 33 are advanced by means of the sliding tube 35 until the receiving part 33 of the frontmost clip 3 has left the catheter tube 1, more precisely, has passed through a blocking element 41 which is mounted on the distal end of the catheter tube 1. After passing through the blocking element 41 this receiving part 33 with the respective clip 3 is in the position shown in FIG. 5.

FIG. 14 which shows the blocking element 41 separately illustrates that the blocking element 41 is a tube piece 43 which lengthens the catheter tube 1 and which has longitudinal slots 44 in its end part so that jaws 45 are formed as a kind of collet and under normal conditions reduce the passage clearance of the tube piece 43. The passage of the receiving part 33 in a slightly elastic way spreads the jaws 45 which assume the blocking position shown in FIGS. 5 to 13 again after emergence of the receiving part 33, so that the receiving part 33, having emerged, is supported against moving backward. A central, projecting shoulder 47 of the receiving part 33 engages as a centering piece between the jaws 45 of the blocking element 41.

FIGS. 5 to 13 illustrate in a highly simplified schematic the progression of the opening and closing cycle of the clip 3 with the receiving part 33, which clip is to be applied and which has been pushed out of the blocking element 41, this entire cycle being effected by pulling on the pull cable 21. FIG. 5 shows the clip 3 activated for application with the sleeve-like receiving part 33 having been pushed out of the blocking element 41, the clip 3 not yet having been pulled into the receiving part 33 by means of the pull cable 21 to the extent that the kink 13 of the legs 5 would strike the beveled control surface 25 of the receiving part 33. The beveled control surface 25 corresponds to the oblique surface 25 on the sleeve 17 already discussed using the operating diagrams 3 and 4.

FIGS. 6 to 9 show the operating states which arise in succession by pulling the pull cable 21, the legs 5 of the clip being progressively opened by the kinks 13 striking the control surface 25 until the state of complete opening is reached as shown in FIG. 9.

FIGS. 10 to 13 shows the closing cycle which results as the pull cable 21 continues to be pulled, the legs 5 for their closing motion effecting closing owing to the inherent elasticity of the clip 3 and/or its deformation being completely released, as soon as the clip 3 has been pulled correspondingly far through the receiving part 33 such that an opening force is no longer being applied by way of the kinks 13. This state is reached when the clip 3 is being pulled further beyond the position shown in FIG. 13 through the receiving part 33. After application which has taken place by the closing of the clip 3 at the hemorrhage site to be treated, in order to completely release the applied clip 3, the pull cable 21 continues to be pulled in order to detach the pull cable of the applied clip which clip is supported with its end which has the end crosspiece 9 (FIG. 2) on the leg end 7 of the clip 3 following next in the catheter tube 1 or on the end edge 37 of the sliding tube 35 from the latter. This takes place by pulling harder on the pull cable 1 in order to apply a detachment force. But preferably provision is made in one alternative embodiment such that the respective clip is supported on a following clip in the magazine when the pull cable 21 is pulled off, but rather that support be accomplished preferably exclusively by way of the sleeve-like receiving part 33. For this support the clip at least partially transversely to its opening direction has blade-like widenings (not shown) on the legs 5 between the leg end 7 and the assignable kink 15 and oppositely adjacent to the latter, which widenings permit an interlocking option of the clip 3 in the sleeve-like receiving part 33 so that the necessary opposing holding force is thus formed for pulling off the pull cable 21 by way of the predetermined breaking point 51. This blade-like widening adjoins flanking on either side of the respective leg 5 of the clip 3.

As can be clearly seen in FIG. 2 a, for this purpose in the end crosspiece 9 which connects the legs 5 of the clip 3 on the back end between the through holes 11 there is a predetermined breaking point 51 which is dimensioned such that the loop 39 of the pull cable 21 effects tearing through of the predetermined breaking point 51 when a predetermined pulling force is applied which in practical embodiments is approximately 40 N. The applied clip 3 with the associated receiving part 33 thus remains at the treatment site, while after the process of tearing off, the pull cable 21 as a loop 39 automatically adjoins the end crosspiece 9 of the following clip which can be advanced by pushing forward by means of the sliding tube 35 for the immediately following application process.

The predetermined breaking point 51 can be made as shown in FIG. 2; but it is also possible to make the predetermined breaking point from a different material which can be easily torn and which is different from that remaining material of the end crosspiece 9. Furthermore, it is also possible to make the end crosspiece 9 uniform in its material to form the predetermined breaking point and the end crosspiece 9 tears if a definable maximum force is exceeded with the pull cable 21. The collet shown in FIG. 14 is fixed with its tube piece 43 as shown in FIG. 1 on the inside circumference of the free end of the catheter tube 1; but it is also possible for the tube piece 43 to enclose the respective free end of the catheter tube 1 and to be held seated there by means of an adhesive connection and/or force fit.

As is to be seen, the entire application process can be carried out by pulling on the pull cable which is provided as the actuation element and which can be a fine steel cable, that is the opening of the respectively activated clip 3 by pulling into the receiving part 33, the release of the pivoting motion of the legs 5 by pulling through the receiving part 33, and the detachment of the pull cable 21 by tearing the predetermined breaking point 51, the pull cable being moved automatically into contact with the end crosspiece 9 of the following clip 3 in the catheter tube 1 so that the device is again immediately ready for the following application process. With the device as claimed in the invention not only it is possible to stop hemorrhages, but the clip can also be used for marking purposes, for example in the field of diagnostics, or also surgical procedures can be carried out in which the clip is used as a surgical instrument, for example for removing polyps in the gastrointestinal tract or the like. 

1. Method for endoscopic application of self-closing medical clips (3), especially for stopping internal hemorrhages, in which a catheter tube (1) with its distal end is placed in the body of the living being to be treated, several clips (3) which are arranged in succession in the catheter tube (1) are advanced by an operator means located on the proximal end of the catheter tube (1) against its distal end, the frontmost clip (3) to be applied is pushed out of the distal end and is opened by an actuating means which has an actuating element (21) which acts on the frontmost clip (3), which can be moved longitudinal in the catheter tube (1) and which can be actuated from the operator means, and has a control part (25) converting its actuating force into an opening motion of the legs (5) of the clip (3), and the actuating element (21) after opening of the clip (3) is detached from the clip (3) in order to release it for the closing of its legs (5) which effects the application and is functionally linked to the clip (3) following in the catheter tube (1).
 2. Device for endoscopic application of self-closing medical clips (3) in the body of a living being, especially for stopping internal hemorrhages, with a catheter tube (1) with a distal end which is to be placed in the body, and a proximal end which is assigned to an operator means, an actuating means (21, 35) extending in the catheter tube (1) from the operator means to the area of the distal end for opening the legs (5) of a clip (3) to be applied, and which has an actuating element (21) which can move longitudinally in the catheter tube (1) and which can be controlled from the operator means, as well as a control part (25) converting its actuating force into an opening motion of the legs (5) of the clip (3), wherein the actuating element (21) acts directly on the clip (3), wherein the control part (25) is provided on the distal end edge of a sleeve-like receiving part (33) which is associated with the clip (3), and into which the clip (3) on part of its length can be inserted by the actuating element (21), and wherein the clip (3) on the two adjacent legs (5) and which support each other in particular areas each have a first kink (13) to the outside which increases the distance of the legs (5) and a following second kink (15) to the inside which is nearer the distal leg end (7) and which forms the point of mutual support of the legs (5), so that the legs are opened by the first kink (13) of the legs (5) striking the control part (25) when the clip (3) is inserted into the sleeve-like receiving part (33).
 3. The device as claimed in claim 2, wherein the actuating element is a pulling element (21) and the control part is a (beveled) control surface (25) located on the end edge of the sleeve-like receiving part (33).
 4. The device as claimed in claim 3, wherein the pulling element is a pull cable (21) and wherein each clip (3) for its connection to the pull cable (21) on its rear end crosspiece (9) connecting the legs (5) has two adjacent through holes (11) through which the pull cable (21) is guided in a loop (39) such that it extends in an advancing strand (24) to the clip (3) and back from the latter back in a retreating strand (24) to the operator means.
 5. The device as claimed in claim 4, wherein the section of the end crosspiece (9) of the clip located between the through holes (11) is made as a predetermined breaking point (51) which can be torn by the pulling force of the pull cable (21) acting by way of the loop (39) in order to detach the pull cable (21) from the clip (3).
 6. The device as claimed in claim 5, wherein on the distal end of the catheter tube (1) there is a blocking element (41) permitting passage of the sleeve-like receiving part (33) with the respective clip (3) only in the exit direction forward but which supports the sleeve-like receiving part (33) however against the motion effected by the pulling force of the pull cable (21).
 7. The device as claimed in claim 6, wherein the blocking element (41) has a tube piece (43) mounted on the end of the catheter tube (1), and which has an end part which is designed as a collet has jaws (45) which run longitudinal, which normally reduce the passage width, and which can be elastically spread out of their normal position by the sleeve-like receiving part (33) of an emerging clip (3), and after returning into the normal position form a support of the emerged receiving part (33) against the pulling force of the pull cable (21).
 8. The device as claimed in claim 4, wherein in the catheter tube (1) there are several clips (3) with the associated sleeve-like receiving part (33) in succession and wherein the pull cable (21) with the advancing strand (24) and with the retreating strand (24) is guided in each case through one or the other through hole (11) of the end crosspieces (9) of all clips (3).
 9. The device as claimed in claim 4, wherein the actuating means for advancing the clip (3) or clips (3) located in the catheter tube (1) with the associated sleeve-like receiving part (33) has a tube (35) which can be moved in the catheter tube (1) and which has an end edge (37) which forms a plunger for contact with the facing back end of the receiving part (33) of the respective clip (3) which is to be advanced.
 10. The device as claimed in claim 7, wherein the back end of the sleeve-like receiving part (33) opposite the beveled control surface (25) has an axially projecting shoulder (47) for centering in the collet-like end part of the blocking element (41). 